A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01358006
First received: May 19, 2011
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: JNJ-40411813
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label Dose-Ranging Study in Healthy Male Subjects to Investigate the Binding Potential of JNJ-40411813 to Serotonin 2A Receptors in the Central Nervous System

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 5-HT2A binding determined by Positron Emission Tomography (PET) scans [ Time Frame: Up to 24 hours after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of JNJ-40411813 [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
  • Adverse Events Reported [ Time Frame: Up to 10 days after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
JNJ-40411813 Cohort 1: Type=2 to 3 unit=mg number=200 to 300 form=capsule route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.,JNJ-40411813 Cohort 2: Type=up to 7 unit=mg number=up to 700 mg form=capsule route=oral use. Capsule(s) taken in the fed state.
Drug: JNJ-40411813
Cohort 1: Type=2 to 3, unit=mg, number=200 to 300, form=capsule, route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.
Drug: JNJ-40411813
Cohort 2: Type=up to 7, unit=mg, number=up to 700 mg, form=capsule, route=oral use. Capsule(s) taken in the fed state.

Detailed Description:

This will be an open-label (volunteers and study staff will know the identity of assigned treatment), dose-ranging study to determine 5-HT2A receptor engagement by JNJ-40411813 as a function of dose and time in healthy male volunteers. The study will consist of an eligibility screening examination, an open-label treatment period and a follow-up examination (approximately 10 days after dose administration, a follow-up examination will be performed). Initially, 4 volunteers (Cohort 1) will be included to determine 5-HT2A receptor occupancy following single dose administration of JNJ-40411813. Dependent on the results, doses for the remaining 8 volunteers (Cohort 2 and 3) will be selected to further characterize 5-HT2A receptor occupancy within the feasible dose range up to maximally 700 mg JNJ-40411813.The maximal study duration for a volunteer will be 6 weeks. In this study, [11C]-MDL 100,907 will be used as positron emission tomography (PET) ligand to investigate the concentration-related binding of 40411813 to the 5-HT2A receptor in the brain. JNJ-40411813 (200 mg to 700 mg) will be taken orally (by mouth). If multiple capsules have to be taken, the actual intake may be spread over a 15-minute period. Study drug will be administered to each volunteer just after completion of a meal and within 30 minutes after the start of the meal.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive
  • Willing to adhere to the prohibitions and restrictions specified in this protocol
  • Volunteers must sign an informed consent to document that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Have abnormal values for clinical laboratory tests, clinically significant abnormal physical examination findings, vital signs, or 12-lead Electrocardiograms (ECGs) performed at screening considered to be of clinical significance to the Investigator
  • Have Significant history of or current significant medical illness that the Investigator considers should exclude the volunteer
  • Have known allergies, hypersensitivity, or intolerance to JNJ-40411813, its excipients, or to the PET ligand used in the study
  • Have significant history of psychiatric or neurological illness in first-degree relatives
  • Been exposed to ionizing radiation as a volunteer (including diagnostic procedures)
  • Presence of other exclusion criteria as specified in the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358006

Locations
Netherlands
Groningen, Netherlands
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01358006     History of Changes
Other Study ID Numbers: CR017485, 40411813EDI1008, 2010-022176-32
Study First Received: May 19, 2011
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
JNJ-40411813
Positron Emission Tomography (PET)
Serotonin-2A (5-HT2A) receptor antagonist
Male Volunteers

ClinicalTrials.gov processed this record on April 20, 2014